Difference between revisions of "Staging page"

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[[#top|Back to Top]]
 
[[#top|Back to Top]]
 
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? See the [[Renal_cell_carcinoma|main RCC page]] for current regimens.
+
{{#lst:Section editor transclusions|tcl}}
 +
''Are you looking for a regimen, but can't find it here? It is possible that we've moved it to the [[Adult T-cell leukemia-lymphoma - historical|historical regimens page]].
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
|-
 
|-
 
|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
 
|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
 
<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
−
|}  
+
|}
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
−
=Metastatic disease, first-line=
+
=Guidelines=
−
==Interferon alfa-2a & Interleukin-2 {{#subobject:77d26e|Regimen=1}}==
+
=="How I Treat"==
 +
*'''2021:''' Cook & Phillips [https://doi.org/10.1182/blood.2019004045 How I treat adult T-cell leukemia/lymphoma]
 +
==[https://www.nccn.org/ NCCN]==
 +
*[https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf NCCN Guidelines - T-cell Lymphomas]
 +
=Untreated=
 +
==CHOP-14 {{#subobject:3e53d9|Regimen=1}}==
 +
CHOP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne every '''<u>14</u>''' days
 +
<br>CHOP-DI: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, '''<u>D</u>'''ose-'''<u>I</u>'''ntense
 +
<br>I-CHOP: '''<u>I</u>'''ntensive '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:89bca8|Variant=1}}===
+
===Regimen {{#subobject:ad2f7b|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
! style="width: 20%" |Study
+
!style="width: 17%"|Study
−
! style="width: 20%" |Years of enrollment
+
!style="width: 15%"|Years of enrollment
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
! style="width: 20%" |Comparator
+
!style="width: 17%"|Comparator
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 17%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
!style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]]
 
|-
 
|-
−
|[https://doi.org/10.1056/NEJM199804303381805 Negrier et al. 1998]
+
|[https://doi.org/10.1093/annonc/mdf287 Itoh et al. 2002 (JCOG 9505)]
−
|1992-1995
+
|1995-1998
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
+
|style="background-color:#1a9851"|Randomized Phase 2 (E-de-esc)
−
|1. [[Renal_cell_carcinoma#High-dose_Interleukin-2|HD IL-2]]<br>2. [[Renal_cell_carcinoma#Interferon_alfa-2a_monotherapy|Interferon alfa-2a]]
+
|[[#Dose-escalated_CHOP_99|dose-escalated CHOP]]
−
| style="background-color:#1a9850" |Superior EFS
+
| style="background-color:#ffffbf" |Did not meet primary endpoint of CR rate
 +
| style="background-color:#1a9850" |Less toxic
 
|-
 
|-
−
|[https://doi.org/10.1007/s00262-009-0773-9 Passalacqua et al. 2009]
+
|[https://doi.org/10.1200/jco.2007.11.9958 Tsukasaki et al. 2007 (JCOG 9801)]
 
|1998-2003
 
|1998-2003
−
| style="background-color:#1a9851" |Phase 3 (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|[[#Interferon_alfa-2a_.26_Interleukin-2|IFN & IL-2]]; maintenance
+
|[[#mLSG15|mLSG15]]
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
+
|style="background-color:#fc8d59"|Seems to have inferior CR rate
−
|-
+
| style="background-color:#1a9850" |Less toxic
−
|[https://doi.org/10.1158/1078-0432.ccr-08-0236 Négrier et al. 2008 (LEONB-PERCY-DUO)]
 
−
|2000-2005
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Interferon_alfa-2a_.26_Interleukin-2|IFN & IL-2]]; IV IL-2
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
 
|-
 
|-
 
|}
 
|}
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Immunotherapy====
+
====Chemotherapy====
−
*[[Interferon alfa-2a (Roferon-A)]]
+
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1
−
*[[Aldesleukin (Proleukin)]]
+
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1
−
</div></div>
+
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1
−
===References===
+
====Glucocorticoid therapy====
−
#Négrier S, Escudier B, Lasset C, Douillard JY, Savary J, Chevreau C, Ravaud A, Mercatello A, Peny J, Mousseau M, Philip T, Tursz T; Groupe Français d'Immunothérapie. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. N Engl J Med. 1998 Apr 30;338(18):1272-8. [https://doi.org/10.1056/NEJM199804303381805 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9562581 PubMed]
+
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5
−
#'''LEONB-PERCY-DUO:''' Négrier S, Perol D, Ravaud A, Bay JO, Oudard S, Chabaud S, Fargeot P, Delva R, Deplanque G, Gravis G, Escudier B; French Immunotherapy Group. Randomized study of intravenous versus subcutaneous interleukin-2, and IFNalpha in patients with good prognosis metastatic renal cancer. Clin Cancer Res. 2008 Sep 15;14(18):5907-12. [https://doi.org/10.1158/1078-0432.ccr-08-0236 link to original article] [https://pubmed.ncbi.nlm.nih.gov/18794104/ PubMed] NCT00416871
+
====Supportive therapy====
−
#Passalacqua R, Buzio C, Buti S, Porta C, Labianca R, Pezzuolo D, Camisa R, Sabbatini R, Benecchi L, Messina C, Cengarle R, Vaglio A, Dalla Chiesa M, Tomasello G, Caminiti C. Phase III, randomised, multicentre trial of maintenance immunotherapy with low-dose interleukin-2 and interferon-alpha for metastatic renal cell cancer. Cancer Immunol Immunother. 2010 Apr;59(4):553-61. Epub 2009 Sep 25. [https://doi.org/10.1007/s00262-009-0773-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19779715 PubMed]
+
*[[Filgrastim (Neupogen)]] given once ANC decreased to less than 1000/uL and continued once per day until count increased to greater than 5000/uL
−
==Interferon alfa-2b monotherapy {{#subobject:6b5be6|Regimen=1}}==
+
'''14-day cycle for 8 cycles'''
−
<div class="toccolours" style="background-color:#eeeeee">
+
====CNS therapy====
−
===Regimen {{#subobject:39f1ab|Variant=1}}===
+
''Intrathecal triple-therapy was given during recovery phase of cycles 1, 3, and 5 after platelet count was greater than 70 × 10<sup>9</sup>/L.''
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
+
*[[Cytarabine (Ara-C)]] 40 mg IT
−
!style="width: 33%"|Study
+
*[[Methotrexate (MTX)]] 15 mg IT
−
!style="width: 33%"|Years of enrollment
+
*[[Prednisone (Sterapred)]] 10 mg IT
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
'''3 doses, total'''
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa003013 Flanigan et al. 2001 (SWOG 8949)]
 
−
|1991-1998
 
−
| style="background-color:#91cf61" |Non-randomized portion of RCT
 
−
|-
 
−
|[https://doi.org/10.1016/S0140-6736(01)06103-7 Mickisch et al. 2001 (EORTC 30947)]
 
−
|1995-1998
 
−
| style="background-color:#91cf61" |Non-randomized portion of RCT
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#cbd5e8">
 
−
====Preceding treatment====
 
−
*[[Surgery#Renal_cell_carcinoma_surgery|Nephrectomy]] versus [[Surgery#No_surgery|no preceding treatment]]
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Immunotherapy====
 
−
*[[Interferon alfa-2b (Intron-A)]]
 
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
#'''EORTC 30947:''' Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; [[Study_Groups#EORTC|EORTC]] Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. [https://doi.org/10.1016/S0140-6736(01)06103-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11583750 PubMed]
+
# '''JCOG 9505:''' Itoh K, Ohtsu T, Fukuda H, Sasaki Y, Ogura M, Morishima Y, Chou T, Aikawa K, Uike N, Mizorogi F, Ohno T, Ikeda S, Sai T, Taniwaki M, Kawano F, Niimi M, Hotta T, Shimoyama M, Tobinai K; [[Study_Groups#JCOG|JCOG]]. Randomized phase II study of biweekly CHOP and dose-escalated CHOP with prophylactic use of lenograstim (glycosylated G-CSF) in aggressive non-Hodgkin's lymphoma: Japan Clinical Oncology Group Study 9505. Ann Oncol. 2002 Sep;13(9):1347-55. [https://doi.org/10.1093/annonc/mdf287 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12196359 PubMed]
−
#'''SWOG 8949:''' Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, Caton JR Jr, Munshi N, Crawford ED. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001 Dec 6;345(23):1655-9. [https://doi.org/10.1056/NEJMoa003013 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11759643 PubMed]
+
<!-- Presented in part at the 47th Annual Meeting of the American Society of Hematology, December 10-13, 2005, Atlanta, GA. -->
−
#'''ECOG E2898:''' NCT00005966
+
# '''JCOG 9801:''' Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; [[Study_Groups#JCOG|JCOG]]. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007 Dec 1;25(34):5458-64. Epub 2007 Oct 29. [https://doi.org/10.1200/jco.2007.11.9958 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17968021 PubMed] NCT00145002
−
==Medroxyprogesterone monotherapy {{#subobject:6c7bb9|Regimen=1}}==
+
==mLSG15 {{#subobject:832886|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:8b5e67|Variant=1}}===
+
===Regimen {{#subobject:1dc050|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
Line 88: Line 77:
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://doi.org/10.1016/S0140-6736(98)03544-2 Ritchie et al. 1999 (MRC RE01)]
+
|[https://doi.org/10.1200/jco.2007.11.9958 Tsukasaki et al. 2007 (JCOG 9801)]
−
|1992-1997
+
|1998-2003
−
| style="background-color:#1a9851" |Phase 3 (C)
+
|style="background-color:#1a9851"|Phase 3 (E-esc)
−
|[[Renal_cell_carcinoma#Interferon_alfa-2a_monotherapy|IFN alfa-2a]]
+
|[[#CHOP-14|CHOP-14]]
−
| style="background-color:#fc8d59" |Seems to have inferior OS
+
|style="background-color:#91cf60"|Seems to have superior CR rate
 
|-
 
|-
−
|[https://doi.org/10.1002/cncr.23056 Negrier et al. 2007 (PERCY Quattro)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024033/ Ishida et al. 2015 (Kyowa 0761-003)]
−
|2000-2004
+
|2010-2011
−
| style="background-color:#1a9851" |Phase 3 (C)
+
|style="background-color:#1a9851"|Randomized Phase 2 (C)
−
|1. [[Renal_cell_carcinoma#Interferon_alfa-2a_monotherapy|IFN alfa-2a]]<br>2. [[#Interferon_alfa-2a_.26_Interleukin-2|IFN alfa-2a & IL-2]]<br>3. [[Renal_cell_carcinoma#Low-dose_Interleukin-2|IL-2]]
+
|[[#mLSG15_.26_Mogamulizumab_99|mLSG15 & Mogamulizumab]]
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
+
|style="background-color:#ffffbf"|Did not meet primary endpoint of CR rate
 
|-
 
|-
 
|}
 
|}
−
''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.''
+
''Ranimustine is not available in the United States and is approved only in Japan.''
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Hormone replacement therapy====
 
−
*[[Medroxyprogesterone (MPA)]]
 
−
</div></div>
 
−
===References===
 
−
#'''MRC RE01:''' Ritchie A, Griffiths G, Parmar M; Medical Research Council Renal Cancer Collaborators. Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Lancet. 1999 Jan 2;353(9146):14-7. [https://doi.org/10.1016/S0140-6736(98)03544-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/10023944 PubMed]
 
−
#'''PERCY Quattro:''' Negrier S, Perol D, Ravaud A, Chevreau C, Bay JO, Delva R, Sevin E, Caty A, Escudier B; French Immunotherapy Intergroup. Medroxyprogesterone, interferon alfa-2a, interleukin 2, or combination of both cytokines in patients with metastatic renal carcinoma of intermediate prognosis: results of a randomized controlled trial. Cancer. 2007 Dec 1;110(11):2468-77. [https://doi.org/10.1002/cncr.23056 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17932908/ PubMed] NCT00416429
 
−
==Vinblastine monotherapy {{#subobject:8c9fac|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:5d6145|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.1999.17.9.2859 Pyrhönen et al. 1999]
 
−
|1988-1994
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Vinblastine_.26_Interferon_alfa-2a_88|Vinblastine & IFN alfa-2a]]
 
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|}
 
−
''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Vinblastine (Velban)]]
+
*[[Vincristine (Oncovin)]] 1 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1
 +
*[[Cyclophosphamide (Cytoxan)]] 350 mg/m<sup>2</sup> IV once on day 1
 +
*[[Doxorubicin (Adriamycin)]] 40 mg/m<sup>2</sup> IV once on day 1, then 30 mg/m<sup>2</sup> IV once on day 8
 +
*[[Ranimustine (Cymerin)]] 60 mg/m<sup>2</sup> IV once on day 8
 +
*[[Vindesine (Eldisine)]] 2.4 mg/m<sup>2</sup> IV once on day 15
 +
*[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 15 to 17
 +
*[[Carboplatin (Paraplatin)]] 250 mg/m<sup>2</sup> IV once on day 15
 +
====Glucocorticoid therapy====
 +
*[[Prednisone (Sterapred)]] 40 mg/m<sup>2</sup> PO once per day on days 1, 8, 15 to 17
 +
'''28-day cycle for 6 cycles'''
 +
====CNS therapy, prophylaxis====
 +
*[[Cytarabine (Ara-C)]] 40 mg IT, admixed with MTX & prednisone
 +
*[[Methotrexate (MTX)]] 15 mg IT, admixed with Ara-C & prednisone
 +
*[[Prednisone (Sterapred)]] 10 mg IT, admixed with Ara-C & MTX
 +
'''Given after cycles 1, 3, and 5 after platelets greater than 70 × 10<sup>9</sup>/L and within 2 days before the next cycle'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# Pyrhönen S, Salminen E, Ruutu M, Lehtonen T, Nurmi M, Tammela T, Juusela H, Rintala E, Hietanen P, Kellokumpu-Lehtinen PL. Prospective randomized trial of interferon alfa-2a plus vinblastine versus vinblastine alone in patients with advanced renal cell cancer. J Clin Oncol. 1999 Sep;17(9):2859-67. [https://doi.org/10.1200/JCO.1999.17.9.2859 link to original article] [https://pubmed.ncbi.nlm.nih.gov/10561363 PubMed]
+
<!-- Presented in part at the 47th Annual Meeting of the American Society of Hematology, December 10-13, 2005, Atlanta, GA. -->
−
=Metastatic disease, second-line=
+
#'''JCOG 9801:''' Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; [[Study_Groups#JCOG|JCOG]]. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007 Dec 1;25(34):5458-64. Epub 2007 Oct 29. [https://doi.org/10.1200/jco.2007.11.9958 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17968021 PubMed] NCT00145002
−
==FC, then allo HSCT {{#subobject:1a1ed9|Regimen=1}}==
+
#'''Kyowa 0761-003:''' Ishida T, Jo T, Takemoto S, Suzushima H, Uozumi K, Yamamoto K, Uike N, Saburi Y, Nosaka K, Utsunomiya A, Tobinai K, Fujiwara H, Ishitsuka K, Yoshida S, Taira N, Moriuchi Y, Imada K, Miyamoto T, Akinaga S, Tomonaga M, Ueda R. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study. Br J Haematol. 2015 Jun;169(5):672-82. Epub 2015 Mar 2. [https://doi.org/10.1111/bjh.13338 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024033/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25733162 PubMed] NCT01173887
−
FC: '''<u>F</u>'''ludarabine & '''<u>C</u>'''yclophosphamide
+
=Relapsed or refractory=
 +
==Alemtuzumab monotherapy {{#subobject:efc45a|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:9ce8f1|Variant=1}}===
+
===Regimen {{#subobject:32e392|Variant=1}}===
−
{| class="wikitable" style="width: 40%; text-align:center;"
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
! style="width: 50%" |Study
+
!style="width: 33%"|Study
−
! style="width: 50%" |[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Years of enrollment
−
|-
+
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
|[https://doi.org/10.1056/NEJM200009143431101 Childs et al. 2000]
 
−
| style="background-color:#ffffbe" |Non-randomized, <20 pts
 
−
|-
 
−
|}
 
−
{{#lst:Allogeneic HSCT|9ce8f1}}
 
−
</div></div>
 
−
===References===
 
−
#Childs R, Chernoff A, Contentin N, Bahceci E, Schrump D, Leitman S, Read EJ, Tisdale J, Dunbar C, Linehan WM, Young NS, Clave E, Epperson D, Mayo V, Barrett AJ. Regression of metastatic renal-cell carcinoma after nonmyeloablative allogeneic peripheral-blood stem-cell transplantation. N Engl J Med. 2000 Sep 14;343(11):750-8. [https://doi.org/10.1056/NEJM200009143431101 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/10984562 PubMed]
 
−
==Interferon alfa-2a monotherapy {{#subobject:8f04d6|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:b28245|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
 
|-
 
|-
−
|[https://doi.org/10.1200/JCO.2005.07.114 Aass et al. 2005 (EORTC 30951)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215752/ Sharma et al. 2016]
−
|1998-2001
+
|2004-2009
−
|style="background-color:#1a9851"|Phase 3 (C)
+
|style="background-color:#91cf61"|Phase 2
−
|[[#Interferon_alfa-2a_.26_Isotretinoin|IFN alfa-2a & Isotretinoin]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior OS
 
 
|-
 
|-
 
|}
 
|}
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Immunotherapy====
+
====Targeted therapy====
−
*[[Interferon alfa-2a (Roferon-A)]]
+
*[[Alemtuzumab (Campath)]] 30 mg IV once per day on days 1, 3, 5 (three times per week)
 +
'''7-day cycle for up to 7 cycles'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# '''EORTC 30951:''' Aass N, De Mulder PH, Mickisch GH, Mulders P, van Oosterom AT, van Poppel H, Fossa SD, de Prijck L, Sylvester RJ. Randomized phase II/III trial of interferon alfa-2a with and without 13-cis-retinoic acid in patients with progressive metastatic renal cell Carcinoma: the European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951). J Clin Oncol. 2005 Jun 20;23(18):4172-8. [https://doi.org/10.1200/JCO.2005.07.114 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15961764 PubMed] NCT00002737
+
<!-- Presented in abstract form at the 50th Annual Meeting of the American Society of Hematology, San Francisco, CA, December 6–9, 2008. -->
−
==Interferon alfa-2a & Isotretinoin {{#subobject:8f038c|Regimen=1}}==
+
# Sharma K, Janik JE, O'Mahony D, Stewart D, Pittaluga S, Stetler-Stevenson M, Jaffe ES, Raffeld M, Fleisher TA, Lee CC, Steinberg SM, Waldmann TA, Morris JC. Phase II study of alemtuzumab (CAMPATH-1) in patients with HTLV-1-associated adult T-cell leukemia/lymphoma. Clin Cancer Res. 2017 Jan 1;23(1):35-42. Epub 2016 Aug 2. [http://clincancerres.aacrjournals.org/content/23/1/35.long link to original article] '''contain protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215752/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27486175 PubMed]
 +
==Lenalidomide monotherapy {{#subobject:b2b90e|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:b52145|Variant=1}}===
+
===Regimen {{#subobject:662944|Variant=1}}===
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 80%; text-align:center;"  
−
!style="width: 20%"|Study
+
!style="width: 25%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 25%"|Years of enrollment
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 20%"|Comparator
+
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.2005.07.114 Aass et al. 2005 (EORTC 30951)]
 
−
|1998-2001
 
−
|style="background-color:#1a9851"|Phase 3 (E-esc)
 
−
|[[#Interferon_alfa-2a_monotherapy|IFN alfa-2a]]
 
−
| style="background-color:#91cf60" |Seems to have superior OS
 
 
|-
 
|-
−
|}
+
|[https://doi.org/10.1200/JCO.2016.67.7732 Ishida et al. 2016 (ATLL-002)]
−
<div class="toccolours" style="background-color:#b3e2cd">
+
|2012-2014
−
====Immunotherapy====
+
|style="background-color:#91cf61"|Phase 2
−
*[[Interferon alfa-2a (Roferon-A)]]
+
|ORR: 42% (95% CI 23-63)
−
*[[Isotretinoin (Accutane)]]
 
−
</div></div>
 
−
===References===
 
−
# '''EORTC 30951:''' Aass N, De Mulder PH, Mickisch GH, Mulders P, van Oosterom AT, van Poppel H, Fossa SD, de Prijck L, Sylvester RJ. Randomized phase II/III trial of interferon alfa-2a with and without 13-cis-retinoic acid in patients with progressive metastatic renal cell Carcinoma: the European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951). J Clin Oncol. 2005 Jun 20;23(18):4172-8. [https://doi.org/10.1200/JCO.2005.07.114 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15961764 PubMed] NCT00002737
 
−
==Interferon alfa-2c monotherapy {{#subobject:31b4d6|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:0f1524|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2033601/ De Mulder et al. 1995 (EORTC 30885)]
 
−
|1988-1990
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Interferon_alfa-2c_.26_Interferon_gamma_99|IFN alfa-2c & IFN gamma]]
 
−
| style="background-color:#ffffbf" |Did not meet efficacy endpoints
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Immunotherapy====
 
−
*[[Interferon alfa-2c (Berofor)]]
 
−
</div></div>
 
−
===References===
 
−
# '''EORTC 30885:''' De Mulder PH, Oosterhof G, Bouffioux C, van Oosterom AT, Vermeylen K, Sylvester R; EORTC Genitourinary Group. EORTC (30885) randomised phase III study with recombinant interferon alpha and recombinant interferon alpha and gamma in patients with advanced renal cell carcinoma. Br J Cancer. 1995 Feb;71(2):371-5. [https://www.nature.com/articles/bjc199575 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2033601/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/7841054 PubMed]
 
−
==Megestrol monotherapy {{#subobject:4b50ea|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:52dc53|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.2007.14.5029 Ravaud et al. 2008]
 
−
|2002-2005
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Lapatinib_monotherapy_99|Lapatinib]]
 
−
|style="background-color:#ffffbf"|Did not meet primary endpoint of TTP
 
 
|-
 
|-
 
|}
 
|}
−
''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.''
 
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
−
====Hormone replacement therapy====
+
====Targeted therapy====
−
*[[Megestrol (Megace)]]
+
*[[Lenalidomide (Revlimid)]] 25 mg PO once per day
 +
'''Continued indefinitely'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
# Ravaud A, Hawkins R, Gardner JP, von der Maase H, Zantl N, Harper P, Rolland F, Audhuy B, Machiels JP, Pétavy F, Gore M, Schöffski P, El-Hariry I. Lapatinib versus hormone therapy in patients with advanced renal cell carcinoma: a randomized phase III clinical trial. J Clin Oncol. 2008 May 10;26(14):2285-91. [https://doi.org/10.1200/JCO.2007.14.5029 link to original article] [https://pubmed.ncbi.nlm.nih.gov/18467719 PubMed]
+
# '''ATLL-002:''' Ishida T, Fujiwara H, Nosaka K, Taira N, Abe Y, Imaizumi Y, Moriuchi Y, Jo T, Ishizawa K, Tobinai K, Tsukasaki K, Ito S, Yoshimitsu M, Otsuka M, Ogura M, Midorikawa S, Ruiz W, Ohtsu T. Multicenter phase II study of lenalidomide in relapsed or recurrent adult T-cell leukemia/lymphoma: ATLL-002. J Clin Oncol. 2016 Dec;34(34):4086-4093. [https://doi.org/10.1200/JCO.2016.67.7732 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27621400 PubMed] NCT01724177
−
[[Category:Renal cell carcinoma regimens]]
+
[[Category:Adult T-cell leukemia-lymphoma regimens]]
−
[[Category:Historical regimens]]
 
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
−
[[Category:Genitourinary cancers]]
+
[[Category:Acute leukemias]]
 +
[[Category:T-cell lymphomas]]
 +
[[Category:T-cell leukemias]]

Revision as of 12:32, 29 October 2022

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Section editor transclusions Are you looking for a regimen, but can't find it here? It is possible that we've moved it to the historical regimens page.

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Guidelines

"How I Treat"

NCCN

Untreated

CHOP-14

CHOP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne every 14 days
CHOP-DI: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne, Dose-Intense
I-CHOP: Intensive Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy Comparative Toxicity
Itoh et al. 2002 (JCOG 9505) 1995-1998 Randomized Phase 2 (E-de-esc) dose-escalated CHOP Did not meet primary endpoint of CR rate Less toxic
Tsukasaki et al. 2007 (JCOG 9801) 1998-2003 Phase 3 (C) mLSG15 Seems to have inferior CR rate Less toxic

Chemotherapy

Glucocorticoid therapy

Supportive therapy

  • Filgrastim (Neupogen) given once ANC decreased to less than 1000/uL and continued once per day until count increased to greater than 5000/uL

14-day cycle for 8 cycles

CNS therapy

Intrathecal triple-therapy was given during recovery phase of cycles 1, 3, and 5 after platelet count was greater than 70 × 109/L.

3 doses, total

References

  1. JCOG 9505: Itoh K, Ohtsu T, Fukuda H, Sasaki Y, Ogura M, Morishima Y, Chou T, Aikawa K, Uike N, Mizorogi F, Ohno T, Ikeda S, Sai T, Taniwaki M, Kawano F, Niimi M, Hotta T, Shimoyama M, Tobinai K; JCOG. Randomized phase II study of biweekly CHOP and dose-escalated CHOP with prophylactic use of lenograstim (glycosylated G-CSF) in aggressive non-Hodgkin's lymphoma: Japan Clinical Oncology Group Study 9505. Ann Oncol. 2002 Sep;13(9):1347-55. link to original article PubMed
  2. JCOG 9801: Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; JCOG. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007 Dec 1;25(34):5458-64. Epub 2007 Oct 29. link to original article contains dosing details in manuscript PubMed NCT00145002

mLSG15

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Tsukasaki et al. 2007 (JCOG 9801) 1998-2003 Phase 3 (E-esc) CHOP-14 Seems to have superior CR rate
Ishida et al. 2015 (Kyowa 0761-003) 2010-2011 Randomized Phase 2 (C) mLSG15 & Mogamulizumab Did not meet primary endpoint of CR rate

Ranimustine is not available in the United States and is approved only in Japan.

Chemotherapy

Glucocorticoid therapy

28-day cycle for 6 cycles

CNS therapy, prophylaxis

Given after cycles 1, 3, and 5 after platelets greater than 70 × 109/L and within 2 days before the next cycle

References

  1. JCOG 9801: Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; JCOG. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007 Dec 1;25(34):5458-64. Epub 2007 Oct 29. link to original article contains dosing details in manuscript PubMed NCT00145002
  2. Kyowa 0761-003: Ishida T, Jo T, Takemoto S, Suzushima H, Uozumi K, Yamamoto K, Uike N, Saburi Y, Nosaka K, Utsunomiya A, Tobinai K, Fujiwara H, Ishitsuka K, Yoshida S, Taira N, Moriuchi Y, Imada K, Miyamoto T, Akinaga S, Tomonaga M, Ueda R. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study. Br J Haematol. 2015 Jun;169(5):672-82. Epub 2015 Mar 2. link to original article link to PMC article PubMed NCT01173887

Relapsed or refractory

Alemtuzumab monotherapy

Regimen

Study Years of enrollment Evidence
Sharma et al. 2016 2004-2009 Phase 2

Targeted therapy

7-day cycle for up to 7 cycles

References

  1. Sharma K, Janik JE, O'Mahony D, Stewart D, Pittaluga S, Stetler-Stevenson M, Jaffe ES, Raffeld M, Fleisher TA, Lee CC, Steinberg SM, Waldmann TA, Morris JC. Phase II study of alemtuzumab (CAMPATH-1) in patients with HTLV-1-associated adult T-cell leukemia/lymphoma. Clin Cancer Res. 2017 Jan 1;23(1):35-42. Epub 2016 Aug 2. link to original article contain protocol link to PMC article PubMed

Lenalidomide monotherapy

Regimen

Study Years of enrollment Evidence Efficacy
Ishida et al. 2016 (ATLL-002) 2012-2014 Phase 2 ORR: 42% (95% CI 23-63)

Targeted therapy

Continued indefinitely

References

  1. ATLL-002: Ishida T, Fujiwara H, Nosaka K, Taira N, Abe Y, Imaizumi Y, Moriuchi Y, Jo T, Ishizawa K, Tobinai K, Tsukasaki K, Ito S, Yoshimitsu M, Otsuka M, Ogura M, Midorikawa S, Ruiz W, Ohtsu T. Multicenter phase II study of lenalidomide in relapsed or recurrent adult T-cell leukemia/lymphoma: ATLL-002. J Clin Oncol. 2016 Dec;34(34):4086-4093. link to original article PubMed NCT01724177
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